Niel Hens1, Aklilu Habteab Ghebretinsae2, Karin Hardt3, Pierre Van Damme4, Koen Van Herck5. 1. Centre for Health Economic Research and Modeling Infectious Diseases (CHERMID), Vaccine & Infectious Disease Institute (WHO Collaborating Centre), University of Antwerp, Wilrijk, Belgium; Center for Statistics (CenStat), Interuniversity Institute of Biostatistics and statistical Bioinformatics (I-BioStat), Hasselt University, Diepenbeek, Belgium. 2. Center for Statistics (CenStat), Interuniversity Institute of Biostatistics and statistical Bioinformatics (I-BioStat), Hasselt University, Diepenbeek, Belgium. 3. GlaxoSmithKline Vaccines, Wavre, Belgium. 4. Centre for the Evaluation of Vaccination (CEV), Vaccine & Infectious Disease Institute (WHO Collaborating Centre), University of Antwerp, Wilrijk, Belgium. Electronic address: pierre.vandamme@ua.ac.be. 5. Centre for the Evaluation of Vaccination (CEV), Vaccine & Infectious Disease Institute (WHO Collaborating Centre), University of Antwerp, Wilrijk, Belgium; Department of Public Health, Ghent University, Ghent, Belgium.
Abstract
BACKGROUND: In this paper, we review the results of existing statistical models of the long-term persistence of hepatitis A vaccine-induced antibodies in light of recently available immunogenicity data from 2 clinical trials (up to 17 years of follow-up). METHODS:Healthy adult volunteers monitored annually for 17 years after the administration of the firstvaccine dose in 2 double-blind, randomized clinical trials were included in this analysis. Vaccination in these studies was administered according to a 2-dose vaccination schedule: 0, 12 months in study A and 0, 6 months in study B (NCT00289757/NCT00291876). Antibodies were measured using an in-house ELISA during the first 11 years of follow-up; a commercially available ELISA was then used up to Year 17 of follow-up. Long-term antibody persistence from studies A and B was estimated using statistical models for longitudinal data. Data from studies A and B were modeled separately. RESULTS: A total of 173 participants in study A and 108 participants in study B were included in the analysis. A linear mixed model with 2 changepoints allowed all available results to be accounted for. Predictions based on this model indicated that 98% (95%CI: 94-100%) of participants in study A and 97% (95%CI: 94-100%) of participants in study B will remain seropositive 25 years after receiving the first vaccine dose. Other models using part of the data provided consistent results: ≥95% of the participants was projected to remain seropositive for ≥25 years. CONCLUSION: This analysis, using previously used and newly selected model structures, was consistent with former estimates of seropositivity rates ≥95% for at least 25 years.
RCT Entities:
BACKGROUND: In this paper, we review the results of existing statistical models of the long-term persistence of hepatitis A vaccine-induced antibodies in light of recently available immunogenicity data from 2 clinical trials (up to 17 years of follow-up). METHODS: Healthy adult volunteers monitored annually for 17 years after the administration of the first vaccine dose in 2 double-blind, randomized clinical trials were included in this analysis. Vaccination in these studies was administered according to a 2-dose vaccination schedule: 0, 12 months in study A and 0, 6 months in study B (NCT00289757/NCT00291876). Antibodies were measured using an in-house ELISA during the first 11 years of follow-up; a commercially available ELISA was then used up to Year 17 of follow-up. Long-term antibody persistence from studies A and B was estimated using statistical models for longitudinal data. Data from studies A and B were modeled separately. RESULTS: A total of 173 participants in study A and 108 participants in study B were included in the analysis. A linear mixed model with 2 changepoints allowed all available results to be accounted for. Predictions based on this model indicated that 98% (95%CI: 94-100%) of participants in study A and 97% (95%CI: 94-100%) of participants in study B will remain seropositive 25 years after receiving the first vaccine dose. Other models using part of the data provided consistent results: ≥95% of the participants was projected to remain seropositive for ≥25 years. CONCLUSION: This analysis, using previously used and newly selected model structures, was consistent with former estimates of seropositivity rates ≥95% for at least 25 years.
Authors: Philip R Spradling; Lisa R Bulkow; Susan E Negus; Chriss Homan; Michael G Bruce; Brian J McMahon Journal: Hepatology Date: 2016-02-01 Impact factor: 17.425
Authors: Noele P Nelson; Mark K Weng; Megan G Hofmeister; Kelly L Moore; Mona Doshani; Saleem Kamili; Alaya Koneru; Penina Haber; Liesl Hagan; José R Romero; Sarah Schillie; Aaron M Harris Journal: MMWR Recomm Rep Date: 2020-07-03
Authors: Pierre Van Damme; Geert Leroux-Roels; P Suryakiran; Nicolas Folschweiller; Olivier Van Der Meeren Journal: Hum Vaccin Immunother Date: 2017-03-10 Impact factor: 3.452